Lithotripsy Probes and Methods for Performing Lithotripsy

ABSTRACT

Various medical devices are described herein. More particularly, various probes used for performing lithotripsy and methods of performing lithotripsy are described. In an example, a probe comprises an elongate member comprising a proximal end, a distal end, a proximal portion, an intermediate portion, and a distal portion. The proximal portion has an outer diameter that is greater than the outer diameter of the distal portion.

RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.13/833,323, filed Mar. 15, 2013, which claims the benefit of U.S.Provisional Application No. 61/616,255, filed Mar. 27, 2012. The entirecontents of each of these related applications are hereby incorporatedinto this disclosure by reference.

FIELD

The disclosure relates generally to medical devices. More particularly,the disclosure relates to devices and methods for performinglithotripsy. Particular embodiments and methods useful in the removal ofstones disposed in various types of bodily passages, such as salivaryducts and the urinary tract, are described.

BACKGROUND

It is sometimes necessary, or otherwise desirable, to remove unwantedmaterials disposed within a bodily passage. For example, lithotripsy—thedisruption and removal of calculi, or stones, from a region of thebody—is frequently performed to remove stones disposed in a salivaryduct or the urinary tract.

Various types of lithotripsy are known, including shockwave lithotripsy,extracorporeal shockwave lithotripsy, laser lithotripsy, percutaneouslithotripsy, endoscopic lithotripsy, and pneumatic lithotripsy. Inpneumatic lithotripsy, a probe attached to a firing handle is advancedthrough a previously placed sheath, or the working channel of a scope,until the distal end of the probe contacts a stone disposed in a bodilypassage. The firing handle is activated to rapidly advance the probe toproduce an impact between the distal end of the probe and the stonecausing its fragmentation and enabling its removal.

Pneumatic lithotripsy can be challenging in relatively small bodypassages, such as the salivary ducts and urinary tract, due to thedeficiencies of probes that utilize a continuous outer diameter. Suchprobes prevent lithotripsy from being performed in small bodily passageswhen the probe has a large outer diameter and increase the tendency ofthe probe to kink along its length when the probe has a small outerdiameter. Moreover, probes having a small outside diameter reduce thecapacity of the probe to transmit power along its length.

In addition, current probes fail to provide a mechanism that allows auser to have fine motor control over the probe while performinglithotripsy. With existing probes, users must rely on gross motorcontrol to perform the procedure. For example, to adjust the length of aprobe disposed in a bodily passage, a user must either manipulate thefiring handle or grasp a portion of the probe itself, which is smoothand relatively small. The lack of fine motor control over the probewhile performing lithotripsy decreases the efficiency of the procedureand increases the likelihood of the probe perforating the wall of thebodily passage and/or causing tissue damage, especially in relativelysmall bodily passages.

Scopes used to perform lithotripsy generally include optics to providevisualization of the stone that is desired to be fragmented and removedfrom the bodily passage. However, in some cases the stone is locatedwithin, or beyond, a curve defined by the wall of the bodily passage, oris offset from the working channel of the scope. Therefore, the scopemust be manipulated (e.g., pushed into the wall of the bodily passage)such that the probe can be advanced to fragment the stone, which canresult in the optics becoming obstructed by the wall of the bodilypassage. This increases the complexity and time required to completeprocedure because it prevents the optics from visualizing contactbetween the probe and the stone during treatment.

Therefore, a need exists for improved devices and methods for use in theperformance of lithotripsy.

BRIEF SUMMARY

Various exemplary medical devices and methods are described andillustrated herein.

An exemplary probe for use in lithotripsy comprises an elongate member,a fitting, an elongate tubular member, and a handle. The elongate membercomprises a first proximal end, a first distal end, a proximal portion,an intermediate portion, and a distal portion. The proximal portion hasa first length and a first outer diameter. The intermediate portion hasa second length and a second outer diameter. The distal portion has athird length and a third outer diameter. The intermediate portion isdisposed between the proximal portion and the distal portion. The firstouter diameter is greater than the third outer diameter and the secondouter diameter of the intermediate portion tapers from the first outerdiameter to the third outer diameter. The fitting is disposed on thefirst proximal end of the elongate member and is adapted to attach theprobe to a lithotripter. The fitting comprises a second proximal end anda second distal end. The elongate tubular member is disposed over aportion of the first length of the proximal portion and comprises athird proximal end that is disposed adjacent to the second distal end ofthe fitting and a third distal end that is disposed proximal to thefirst distal end of the elongate member. The handle is disposed on theelongate member and comprises a fourth proximal end that is attached tothe third distal of the elongate tubular member and a fourth distal end.

Another exemplary probe for use in lithotripsy comprises an elongatemember, a fitting, an elongate tubular member, and a handle. Theelongate member comprises a first proximal end, a first distal end, aproximal portion, an intermediate portion, and a distal portion. Theproximal portion has a first length and a first outer diameter. Theintermediate portion has a second length and a second outer diameter.The distal portion has a third length and a third outer diameter. Theintermediate portion is disposed between the proximal portion and thedistal portion. The first outer diameter is greater than the third outerdiameter and the second outer diameter of the intermediate portiontapers from the first outer diameter to the third outer diameter. Thefitting is disposed on the first proximal end of the elongate member andis adapted to attach the probe to a lithotripter. The fitting comprisesa second proximal end and a second distal end. The elongate tubularmember is disposed over a portion of the first length of the proximalportion and comprises a third proximal end that is disposed adjacent tothe second distal end of the fitting and a third distal end that isdisposed proximal to the intermediate portion. The handle is disposedover the intermediate portion of the elongate member and comprises afourth proximal end that is attached to the third distal of the elongatetubular member and a fourth distal end.

An exemplary method of performing lithotripsy on a stone disposed in abodily passage comprises the steps of: inserting a sheath that has afirst proximal end, a first distal end, and that defines a first lumeninto the bodily passage such that the first distal end is disposed inthe bodily passage; inserting a scope that has a second proximal end, asecond distal end, and that defines a second lumen through the firstlumen such that the second distal end is disposed distal to the firstdistal end of the sheath; inserting a lithotripter comprising a firinghandle and a probe having a third proximal end and a third distal endthrough the second lumen such that the third distal end is disposeddistal to the second distal end of the scope; navigating the thirddistal end of the probe towards the stone; contacting the third distalend of the probe with the stone; and activating the firing handle of thelithotripter to fragment the stone.

Additional understanding of the exemplary medical devices and methodscan be obtained by review of the detailed description, below, and theappended drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of an exemplary probe.

FIG. 1A is a side view of another exemplary probe.

FIG. 2 is a side view of another exemplary probe.

FIG. 3 is a perspective view of another exemplary probe with anassociated elongate tubular member and handle.

FIG. 4 is a magnified view of area 4 indicated in FIG. 3.

FIG. 5 is an exploded view of the elongate tubular member and handleillustrated in FIG. 3.

FIG. 5A is a side view of another exemplary probe with an associatedhandle.

FIG. 6 is a partial sectional view of an exemplary probe and sheathpartially disposed in a bodily passage.

FIG. 7 is a partial cross sectional view of an exemplary probe, sheath,and scope partially disposed in a bodily passage.

FIG. 7A is a cross sectional view of the distal end of the exemplaryprobe illustrated in FIG. 1A and the sheath and scope illustrated inFIG. 7 partially disposed in a bodily passage. The probe is in a firststraight configuration.

FIG. 7B is a cross sectional view of the distal end of the exemplaryprobe illustrated in FIG. 1A and the sheath and scope illustrated inFIG. 7 partially disposed in a bodily passage. The probe is in a secondcurved configuration.

FIG. 8 is a flowchart representation of an exemplary method oftreatment.

FIG. 9 is a flowchart representation of another exemplary method oftreatment.

DETAILED DESCRIPTION

The following detailed description and the appended drawings describeand illustrate various exemplary devices and methods. The descriptionand drawings are exemplary in nature and are provided to enable oneskilled in the art to make and use one or more exemplary devices and/orpractice one or more exemplary methods. They are not intended to limitthe scope of the claims in any manner.

The use of “e.g.,” “etc.,” “for instance,” “in example,” and “or” andgrammatically related terms indicates non-exclusive alternatives withoutlimitation, unless otherwise noted. The use of “optionally” andgrammatically related terms means that the subsequently describedelement, event, or circumstance may or may not be present/occur, andthat the description includes instances where said element, event, orcircumstance occurs and instances where it does not. As used herein, theterms “proximal” and “distal” are used to describe opposing axial endsof the particular elements or features being described. The term “bodilypassage” refers to any passage within the body of an animal, including,but not limited to, humans, and includes elongate passages. The term“salivary duct” refers to the parotid ducts, submandibular ducts, and/orsublingual ducts. The term “papilla” refers to the projection andopening formed at the end of a salivary duct. The term “urinary tract”refers to the kidneys, renal pelvis, ureters, bladder, urethra, and/orany other portion of the urinary system. The term “attached” refers tothe fixed, releasable, or integrated association of two or more elementsand/or devices. Thus, the term “attached” includes releasably attachingor fixedly attaching two or more elements. The term “exemplary” refersto “an example of” and is not intended to convey a meaning of an idealor preferred embodiment.

FIG. 1 illustrates an exemplary probe 100 comprising an elongate member101, fitting 130, and an O-ring 150.

The elongate member 101 comprises a proximal end 102, distal end 104,proximal portion 106, intermediate portion 108, and distal portion 110.Proximal portion 106 extends from the proximal end 102 to theintermediate portion 108 and has an outer diameter 112 and a length 114that extends distal to fitting 130. Proximal portion 106 has a uniform,or substantially uniform, outer diameter 112 and is rigid, orsubstantially rigid, relative to the distal portion 110. Proximalportion 106 can have any suitable outer diameter 112 and length 114, andskilled artisans will be able to select a suitable outer diameter andlength for the proximal portion of an elongate member according to aparticular embodiment based on various considerations, such as thenature of the bodily passage, the inner diameter of the lumen of a scopeor sheath within which the probe is intended to be used, the amount ofenergy desired to be transmitted to the distal end of the elongatemember, and the desired flexibility of the elongate member. The inventorhas determined that an outer diameter 112 between about 0.25 millimetersand about 2.75 millimeters is suitable. In addition, the inventor hasdetermined that an outer diameter 112 between about 0.5 millimeters andabout 2.5 millimeters is suitable. Furthermore, the inventor hasdetermined that an outer diameter 112 about, equal to, or substantiallyequal to, 1.0 millimeter is considered suitable. Moreover, the inventorhas determined that when the proximal portion 106 is formed of nickeltitanium, an outer diameter 112 about, equal to, substantially equal to,or greater than 1.0 millimeter is considered suitable.

Intermediate portion 108 extends between proximal portion 106 and distalportion 110 and has a length 120 and an outer diameter that tapers fromthe proximal portion 106 to the distal portion 110. Intermediate portion108 can have any suitable outer diameter and length 120, and a skilledartisan will be able to select a suitable outer diameter and length 120for the intermediate portion 108 of an elongate member according to aparticular embodiment based on various considerations, such as thenature of the bodily passage, the inner diameter of the lumen of a scopeor sheath within which the probe is intended to be used, the amount ofenergy desired to be transmitted to the distal end of the elongatemember, and the desired flexibility of the elongate member. An exampleof a length 120 considered suitable for intermediate portion 108 is alength 120 that is less than the length 114 of proximal portion 106 andthe length 118 of distal portion 110. The inventor has determined thatan intermediate portion 108 having a length 120 between about 2millimeters and about 10 millimeters is suitable. Moreover, the inventorhas determined that an intermediate portion 108 having a length 120between about 5 millimeters and about 30 millimeters is suitable. Inaddition, the inventor has determined that an intermediate portion 108having a length 120 about, equal to, or substantially equal to, 5millimeters is considered suitable. Furthermore, the inventor hasdetermined that an intermediate portion 108 having a length 120 about,equal to, or substantially equal to, 22 millimeters is consideredsuitable.

Distal portion 110 extends from intermediate portion 108 to the distalend 104 of the elongate member 101. Distal portion 110 has a length 118and a uniform, or substantially uniform, outer diameter 116. Distalportion 110 is flexible, or substantially flexible, such that it cannavigate through any curves defined along the length of a scope orsheath and/or within tortuous bodily passages. Distal portion 110 canhave any suitable outer diameter 116 and length 118, and skilledartisans will be able to select a suitable outer diameter and length forthe distal portion of an elongate member according to a particularembodiment based on various considerations, such as the nature of thebodily passage and/or the inner diameter of the lumen of a scope orsheath through which a probe is intended to be used. It is consideredadvantageous for distal portion 110 to have an outer diameter 116 thatis adapted to be passed through the lumen of a scope or sheath.

The inventor has determined that an outer diameter 116 between about 0.1millimeters and about 1.0 millimeter is suitable. In addition, theinventor has determined that an outer diameter 116 between about 0.25millimeters and about 0.75 millimeters is suitable. Furthermore, theinventor has determined that an outer diameter 116 of about, equal to,or substantially equal to, 0.56 millimeters is considered suitable.Moreover, the inventor has determined that an outer diameter 116 about,equal to, or substantially equal to, 0.40 millimeters is consideredsuitable.

The inventor has also determined that an outer diameter 116 betweenabout 0.01 millimeter and about 0.15 millimeters smaller than the innerdiameter of the lumen of a scope or sheath through which a probe isintended to be used is considered suitable. In addition, the inventorhas determined that an outer diameter 116 between about 0.025millimeters and about 0.125 millimeters smaller than the inner diameterof the lumen of a scope or sheath through which a probe is intended tobe used is considered suitable. Furthermore, the inventor has determinedthat an outer diameter 116 between about 0.05 millimeters and about 0.10millimeter smaller than the inner diameter of the lumen of a scope orsheath through which a probe is intended to be used is consideredsuitable. Moreover, the inventor has determined that an outer diameter116 about, equal to, or substantially equal to, 0.05 millimeters smallerthan the inner diameter of the lumen of a scope or sheath through whicha probe is intended to be used is considered suitable.

The length 118 of distal portion 110 will vary depending on the intendeduse of probe 100 and on the portion of probe 100 that will be passedthrough the lumen of a scope or sheath. For example, when the distal end104 of elongate member 101 is being used within a salivary duct, onlythe distal portion 110 of elongate member 101 will be passed through thelumen of a scope or sheath. However, while a particular portion of probe100 has been described as being passed through the lumen of a scope orsheath, other portions of probe 100 are considered suitable to passthrough the lumen of a scope or sheath. Skilled artisans will be able toselect a suitable portion to pass through the lumen of a scope or sheathbased on various considerations, such as the nature of the bodilypassage and/or the inner diameter of the lumen of a scope or sheathwithin which the probe is intended to be used. The inventor hasdetermined that a distal portion 110 having a length 118 that is betweenabout 0.5 centimeters and about 3.5 centimeters greater than the lengthof the lumen of the sheath and/or scope that the distal portion 110 isbeing passed through is considered suitable. Also, the inventor hasdetermined that a distal portion 110 having a length 118 that is betweenabout 1.5 centimeters and about 2.5 centimeters greater than the lengthof the lumen of the sheath and/or scope that the distal portion 110 isbeing passed through is considered suitable. In addition, the inventorhas determined that a distal portion 110 having a length 118 about,equal to, or substantially equal to 1.0 centimeter greater than thelength of the lumen of the sheath and/or scope that the distal portion110 is being passed through is considered suitable. Also, the inventorhas determined that a distal portion 110 having a length 118 about,equal to, or substantially equal to 1.5 centimeters greater than thelength of the lumen of the sheath and/or scope that the distal portion110 is being passed through is considered suitable. Moreover, theinventor has determined that a distal portion 110 having a length 118about, equal to, or substantially equal to 2.0 centimeters greater thanthe length of the lumen of the sheath and/or scope that the distalportion 110 is being passed through is considered suitable. It isconsidered advantageous to only pass a small length of a probe distal tothe distal end of the sheath and/or scope that a probe is being passedthrough to ensure that the unsupported portion (e.g., the length ofprobe disposed distal to the distal end of the sheath and/or scope) islimited to maintain power transferred along the length of the probe by alithotripter, or other device.

It is considered advantageous to provide a proximal portion 106 that hasan outer diameter 112 greater than the outer diameter 116 of distalportion 110 to allow distal portion 110 to be used in bodily passages,or devices, defining a lumen that has a diameter smaller than the outerdiameter 112 of proximal portion 106. Furthermore, the structuralrelationship between proximal portion 106 and distal portion 110provides more efficient transmission of power along the length ofelongate member 101 when lithotripsy is being performed as compared to aprobe having a small continuous outer diameter along its length.

It is also considered advantageous to provide a proximal portion 106that is rigid, or substantially rigid, relative to the distal portion110 that is flexible, or substantially flexible, to allow distal portion110 to be navigated through tortuous passages. For example, it isconsidered advantageous to provide a proximal portion 106 that isrelatively rigid relative to a distal portion 110, and a distal portion110 that is flexible relative to a proximal portion 110.

Elongate member 101 can be formed of any suitable material andmanufactured using any suitable method, and skilled artisans will beable to select a suitable material to form an elongate member and methodof manufacture for a particular embodiment based on variousconsiderations, such as the desired outer diameter of the proximalportion and/or distal portion of the probe. Example materials consideredsuitable to form an elongate member include, but are not limited to,biocompatible materials, materials that can be made biocompatible,stainless steel, nickel titanium, cobalt chromium, plastics, polymers,and any other suitable material or combination. The proximal portion106, intermediate portion 108, and/or distal portion 110 of elongatemember 101 can be formed of the same material, or formed of differentmaterials. For example, distal portion 110 can be formed of nickeltitanium to provide flexibility, and allowing distal portion 110 to bepassed through tortuous passages. An example method of manufactureconsidered suitable includes, but is not limited to, centerless grindingof a mandrel to form the probes described herein. Another example methodof manufacture considered suitable includes forming intermediate portion108 and distal portion 110 by inserting nickel titanium into a cannulahaving a tapered distal end.

In the illustrated embodiment, distal portion 110 of the elongate member101 comprises one or more indicia 111 disposed along its length 118. Theone or more indicia 111 can be formed on the outer surface of distalportion 110, or be embedded within the material forming distal portion110. The one or more indicia 111 can be disposed at equal, or varying,lengths and can be used to determine the amount of elongate member 101disposed within the lumen of a scope, sheath, and/or a bodily passage.Alternatively, each of the one or more indicia 111 can comprise a raisedprotuberance extending radially outward from the exterior surface ofdistal portion 110. The raised protuberance can extend about theentirety of the circumference, or a portion of the circumference, ofdistal portion 110. Optionally, the one or more indicia 111 can beomitted from inclusion with distal portion 110.

While the distal portion 110 of the elongate member 101 has beenillustrated and described as having one or more indicia 111 disposedalong its length, any suitable portion of elongate member 101 caninclude one or more indicia, and skilled artisans will be able to selecta suitable portion of an elongate member to include one or more indiciaaccording to a particular embodiment based on various considerations,such as the nature of the bodily passage and/or the inner diameter ofthe lumen of a scope or sheath within which a probe is intended to beused. Example portions of an elongate member that are consideredsuitable to include one or more indicia include, but are not limited to,proximal portion 106, and intermediate portion 108. For example,proximal portion can include one or more indicia disposed along itslength to determine the length of elongate member 101 disposed withinthe lumen of a sheath, scope, and/or bodily passage.

Fitting 130 is disposed on the proximal end 102 of the elongate member101. Fitting 130 provides a mechanism for attaching probe 100 to thehandle of a lithotripter allowing the lithotripter to transfer energy toprobe 100 when a firing handle is activated. Fitting 130 comprises atubular member 131 that has a proximal end 132, a distal end 134, afirst outer diameter 133, a second outer diameter 135, a first member136, a second member 138, and defines a lumen 140. The first outerdiameter 133 extends from the distal end 134 towards the proximal end132 to second member 138. The second outer diameter 135 extends betweenthe first member 136 and second member 138. The first member 136 extendsradially outward from the proximal end 132 of tubular member 131 and hasa third outer diameter 137 that is greater than the second outerdiameter 135 of tubular member 131. The second member 138 extendsradially outward from tubular member 131, is disposed between the firstmember 136 and the distal end 134 of tubular member 131, and has afourth outer diameter 139 that is greater than the second outer diameter135 of tubular member 131.

Fitting 130 is disposed on the proximal end 102 of elongate member 101by inserting the proximal end 102 of elongate member 101 through thelumen 140 of fitting 130. Fitting 130 can be attached to elongate member101 using any suitable method of attachment, and a skilled artisan willbe able to select a suitable method to attach a fitting to an elongatemember according to a particular embodiment based on variousconsiderations, such as the intended use of the probe. Example methodsof attachment between a fitting and an elongate member consideredsuitable include, but are not limited to, using an adhesive, welding,threading, crimping, using integrated elements, and/or a combination ofthese methods or any other suitable method. It is consideredadvantageous to attach fitting 130 to elongate member 101 by threadingand/or crimping the tubular member 131 of fitting 130 at one or morelocations between the proximal end 132 and distal end 134 of fitting orbetween first member 136 and the second member 138 at least because itreduces the likelihood of fitting 130 becoming detached, and/or loose,from elongate member 101 during use.

Fitting 130 can be formed of any suitable material, manufactured usingany suitable method, and form any suitable structure adapted to attach aprobe to a housing, handle, and/or lithotripter. Skilled artisans willbe able to select a suitable material to form a fitting, method ofmanufacture, and structure for a particular embodiment based on variousconsiderations, such as the desired housing, handle, and/or lithotripterto which a probe is intended to be attached. Example materialsconsidered suitable to form a fitting include, but are not limited to,biocompatible materials, materials that can be made biocompatible,stainless steel, nickel titanium, cobalt chromium, plastics, and anyother suitable material or combination thereof.

Each of the first outer diameter 133, second outer diameter 135, thirdouter diameter 137, and fourth outer diameter 139 can have any suitablelength, and skilled artisans will be able to select suitable lengthsaccording to a particular embodiment based on various considerations,including the desired housing, handle, and/or lithotripter to which aprobe is intended to be attached. Example lengths considered suitableinclude, but are not limited to, a first outer diameter that is greaterthan the second outer diameter, a first outer diameter that is equal to,or substantially equal to, the second outer diameter, and a first outerdiameter that is less than the second outer diameter. The inventor hasdetermined that a first outer diameter 133 that is greater than thesecond outer diameter 135 is considered advantageous at least becauseoptimal crimping of fitting 130 to elongate member 101 can beaccomplished. This can be accomplished, for example, by providing afitting 130 that has a tubular member 131 that defines a first thicknessalong the length of the tubular member 131 that defines the first outerdiameter 133 and a second thickness along the length of the tubularmember 131 that defines the second outer diameter 135 such that thefirst thickness is greater than the second thickness.

O-ring 150 is disposed between the second member 138 and the distal end134 of tubular member 131. O-ring 150 provides a mechanism for dampeningthe engagement between probe 100 and the handle of a lithotripter whenin use. O-ring 150 comprises a body 151 that defines an aperture 152 andan outer diameter 154. The aperture 152 has an inner diameter that isequal to, or less than, the first outer diameter 133 of tubular member131 so that releasable attachment between O-ring 150 and fitting 130 canbe accomplished by a friction fit between the O-ring 150 and fitting130.

Any suitable O-ring, formed of any suitable material, defining anysuitable inner diameter and outer diameter can be utilized, and skilledartisans will be able to select a suitable O-ring, material, innerdiameter, and outer diameter for an O-ring according to a particularembodiment based on various considerations, such as the outer diameterof the fitting and/or elongate member. It is considered advantageous toform an O-ring of a flexible, or substantially flexible, material toprovide dampening of the engagement between a probe and the handle of alithotripter when in use.

While fitting 130 and O-ring 150 have been described and illustrated asdisposed on elongate member 101, fitting 130 and O-ring 150 canoptionally be omitted from probe 100, or alternative structures can beutilized to provide a mechanism to attach a probe 100 to a housing,handle, and/or lithotripter. Skilled artisans will be able to select asuitable structure (e.g., fitting, O-ring) to include with a probeaccording to a particular embodiment based on various considerations,such as the structure of the housing, handle, or lithotripter to which aprobe is intended to be attached. For example, a fitting and an elongatemember can be a unitary, integral, component. This can be accomplished,for example, by centerless grinding a fitting, such as those describedherein, on the proximal end of an elongate member.

Alternative to the structural arrangement illustrated and describedabove, an elongate member can define a member that extends outward andaway (e.g., radially outward) from the proximal portion about a portion,or the entirety, of the circumference of the proximal portion and alonga portion of the length of the proximal portion. It is consideredadvantageous for the member to be positioned on the proximal end of theelongate member. The member can be an integral portion of the elongatemember, or attached to the elongate member using any suitable technique,such as those described herein. In addition, the fitting can define arecess on the proximal end of the fitting (e.g., about the lumen offitting) that corresponds with, or is complementary to, the structuralarrangement of the member disposed on the elongate member. Thus,elongate member has a stepped configuration on the proximal end that isadapted to, or is disposed within, a recess defined by fitting on thefitting proximal end. This structural arrangement is consideredadvantageous at least because it provides a mechanism for preventingdistal advancement of the elongate member beyond a location where themember of the elongate member is disposed within the recess defined bythe fitting.

FIG. 1A illustrates another exemplary probe 100′ that is similar toprobe 100, except as described. Reference numbers in FIG. 1A refer tothe same structural element or feature referenced by the same number inFIG. 1, offset by ′. Thus, probe 100′ comprises an elongate member 101′,a fitting 130′ disposed on the proximal end 102′ of elongate member101′, and an O-ring 150′ disposed between the second member 138′ thedistal end 134′ of fitting 130′.

In the illustrated embodiment, elongate member 101′ defines an elongatemember curve 155′ between elongate member distal end 104′ andintermediate portion 108′. Elongate member 101′ is adapted to movebetween a curved configuration, as shown in FIG. 1A, to a straight, orsubstantially straight, configuration, as described in more detailherein. In the straight, or substantially straight, configuration theportion of elongate member 101′ that defines elongate member curve 155′is straight, or substantially straight, when it is disposed in a lumendefined by a device (e.g., lumen of scope, lumen of sheath). When freeof the lumen, elongate member 101′ is biased to the curvedconfiguration. It is considered advantageous to form elongate member101′ of a material that allows torque to be transferred along the lengthof elongate member 101′ at least because this provides a mechanism forrotating elongate member 101′ and positioning it at a desired point oftreatment.

Elongate member 101′ has an elongate member first axis 157′ and anelongate member second axis 159′ disposed at an angle to elongate memberfirst axis 157′. Elongate member first axis 157′ extends along aportion, or the entirety, of elongate member 101′ disposed proximal toelongate member curve 155′ (e.g., proximal portion 106′). Elongatemember second axis 157′ extends through elongate member first axis 157′,through a portion of elongate member 101′ disposed distal to elongatemember curve 155′ and/or through elongate member distal end 104′.

Elongate member 101′ can define any suitable angle between the elongatemember first axis 157′ and elongate member second axis 159′, and skilledartisans will be able to select a suitable angle to define between anelongate member first axis and an elongate member second axis accordingto a particular embodiment based on various considerations, includingthe procedure intended to be performed. Example angles consideredsuitable to define between an elongate member first axis and an elongatemember second axis include, but are not limited to, acute angles, obtuseangles, a 45 degree angle, a substantially 45 degree angle, a 90 degreeangle, a substantially 90 degree angle, a 135 degree angle, asubstantially 135 degree angle, and any other angle considered suitablefor a particular application. The inventor has determined that anglesthat offset the elongate member distal end 104′ from the elongate memberfirst axis 157′ between about 0.1 millimeters to about 5 millimeters areconsidered advantageous. The inventor has also determined that anglesthat offset the elongate member distal end 104′ from the elongate memberfirst axis 157′ between about 0.5 millimeters to about 3 millimeters areconsidered advantageous. The inventor has also determined that greaterdistances are considered advantageous in settings in which the elongatemember 101′ is used in bodily passages other than the salivary ducts.

Curve 155′ can be formed on elongate member 101′ using any suitabletechnique, and skilled artisans will be able to select a suitabletechnique to form a curve on an elongate member according to aparticular embodiment based on various considerations, including thematerial forming an elongate member. An example technique consideredsuitable to form a curve on an elongate member includes, but is notlimited to, positioning the elongate member in the second curvedconfiguration and then applying heat to the portion of the elongatemember length in which it is desired to form a curve such that the curveis incorporated into the material forming the elongate member.Alternative to defining a curve 155′, an elongate member can define abend along the length of elongate member 101′. It is consideredadvantageous for elongate member 101′ to be formed of a material thatallows elongate member curve 155′ and elongate member distal end 104′ tobe torqued during treatment at least because this provides a mechanismfor positioning elongate member distal end 104′ at a point of treatment.

While curve 155′ has been illustrated as defined between elongate memberdistal end 104′ and intermediate portion 108′, a curve can be definedalong any suitable portion, or the entirety, of the length of anelongate member. Skilled artisans will be able to select a suitableportion of an elongate member length to define a curve according to aparticular embodiment based on various considerations, including thematerial forming the elongate member. Example portions of an elongatemember length considered suitable to define a curve include, but are notlimited to, defining a curve between an elongate member proximal end andan elongate member distal end, between an elongate member distal end andan intermediate portion, between an elongate member distal end and aproximal portion, between an elongate member distal end and a fitting,between a fitting and an intermediate portion, along an intermediateportion, and any other portion of an elongate member length consideredsuitable for a particular application.

The inclusion of curve 155′ on elongate member 101′ is consideredadvantageous at least because it provides a mechanism for advancingprobe 100′ through the tortuous anatomy of a bodily passage and towardsa point of treatment. For example, when probe 100′ is passed through alumen defined by a scope, probe 100′ can be advanced through thetortuous anatomy of the bodily passage without requiring manipulation ofthe scope, which may result in the optics becoming obstructed by thewall of the bodily passage, or otherwise.

FIG. 2 illustrates another exemplary probe 200 that is similar to probe100, except as described. Reference numbers in FIG. 2 refer to the samestructural element or feature referenced by the same number in FIG. 1,offset by 100. Thus, the probe 200 comprises an elongate member 201, afitting 230 disposed on the proximal end of elongate member 201, and anO-ring 250 disposed between the second member 238 the distal end 234 offitting 230.

In this embodiment elongate member 201 defines a shoulder 240 instead ofan intermediate portion, such as intermediate portion 108 illustrated inFIG. 1. Thus, elongate member 201 comprises a proximal end 202, distalend 204, proximal portion 206, distal portion 210, and defines shoulder240. Proximal portion 206 extends from the proximal end 202 to thedistal portion 210 and has a length 214 that extends distal to fitting230. Proximal portion 206 has a uniform, or substantially uniform, outerdiameter 212, is rigid, or substantially rigid, and can have anysuitable outer diameter 212 and length 214. A skilled artisan will beable to select a suitable outer diameter 212 and length 214 for theproximal portion 206 of an elongate member 201 according to a particularembodiment based on various considerations, such as the nature of thebodily passage and/or the inner diameter of the lumen of a scope orsheath within which the probe is intended to be used, the amount ofenergy desired to be transmitted to the distal end of the elongatemember, and the desired flexibility of the elongate member.

Distal portion 210 extends from proximal portion 206 to the distal end204 of elongate member 201 and has a length 218 and a uniform, orsubstantially uniform, outer diameter 216. Distal portion 210 isflexible, or substantially flexible, and can have any suitable outerdiameter 216 and length 218. A skilled artisan will be able to select asuitable outer diameter 216 and length 218 for the distal portion 210 ofan elongate member according to a particular embodiment based on variousconsiderations, such as the nature of the bodily passage and/or theinner diameter of the working channel of a scope or lumen of a sheathwithin which the probe is intended to be used, the amount of energydesired to be transmitted to the distal end of the elongate member, andthe desired flexibility of the elongate member.

Elongate member 201 defines shoulder 240 at a location between theproximal end 202 and the distal end 204 of elongate member 201 thatreduces the outer diameter 212 of proximal portion 206 to the outerdiameter 216 of distal portion 210. Thus, the outer diameter 212 ofproximal portion 206 is greater than the outer diameter 216 of distalportion 210. It is considered advantageous to define a shoulder 240between the proximal end 202 and the distal end 204 of an elongatemember 201 to provide a mechanism for preventing advancement of probe200 distally through the lumen of a probe or sheath, beyond shoulder 240when the outer diameter 212 of proximal portion 206 is greater than theinner diameter of the lumen of the scope or sheath.

FIGS. 3 and 4 illustrate an exemplary probe 300. Reference numbers inFIGS. 3 and 4 refer to the same structural element or feature referencedby the same number in FIG. 1, offset by 200. Probe 300 comprises anelongate member 301, a fitting 330 disposed on the proximal end ofelongate member 301, an O-ring 350 disposed between the second member338 and the distal end 334 of fitting 330, an elongate tubular member360, and handle 370. The elongate member 301, fitting 330, and O-ring350 are similar to the elongate member 101, fitting 130, and O-ring 150described with respect to FIG. 1, except as described.

In this embodiment, elongate tubular member 360 and handle 370 aredisposed along a portion of the length of elongate member 301. Handle370 has a first configuration and a second configuration. In the firstconfiguration, the elongate tubular member 360 and handle 370 areslidably disposed along a portion of the length of elongate member 301.In the second configuration, the elongate tubular member 360 and handle370 are releasably attached to elongate member 301. The inclusion of anelongate tubular member 360 and handle 370 is considered advantageous atleast because it provides a user with the ability to have fine motorcontrol over the probe 300 during the performance of lithotripsy andprovides a mechanism to prevent the distal end 304 of elongate member301 from being inserted beyond a desired point into a scope, sheath,and/or bodily passage.

Elongate member 301 comprises a proximal end 302, distal end 304,proximal portion 306, intermediate portion 308, and distal portion 310.Elongate tubular member 360 is slidably disposed over a length ofelongate member 301 and comprises a proximal end 362 and a distal end364. Elongate tubular member 360 has a length 365, an outer diameter366, and defines a lumen 367 that forms an opening at the proximal end362 and an opening at the distal end 364. The proximal end 362 ofelongate tubular member 360 is disposed adjacent the distal end 334 offitting 330 and the distal end 364 of elongate tubular member 360 isdisposed proximal to intermediate portion 308 of elongate member 301.Alternatively, the distal end 364 of elongate tubular member 360 can bedisposed at any point along the length of elongate member 301 (e.g., at,or near, intermediate portion 308). The lumen 367 of elongate tubularmember 360 has an inner diameter that is greater than the outer diameter312 of proximal portion 306 to allow for slidable engagement between theelongate tubular member 360 and elongate member 301 when the elongatetubular member 360 is disposed along a portion of the length of elongatemember 301.

While elongate tubular member 360 has been described as having aparticular length 365, elongate tubular member 360 can have any suitablelength, and skilled artisans will be able to select a suitable lengthfor an elongate tubular member according to a particular embodimentbased on various considerations, such as the desired positioning ofhandle 370 along the length of elongate member 301. Example lengthsconsidered suitable for the elongate tubular member 360 include lengthsthat position the distal end 364 of elongate tubular member 360 betweenproximal portion 306 and intermediate portion 308, along the length ofintermediate portion 308, between intermediate portion 308 and distalportion 310, or along the length of distal portion 310 when the proximalend 362 of elongate tubular member 360 is disposed adjacent to thedistal end 334 of fitting 330. It is considered advantageous to providean elongate tubular member 360 with a length 365 that positions handle370 at least over intermediate portion 308 of probe 300 when theproximal end 362 of elongate tubular member 360 is positioned adjacentto the distal end 334 of the fitting 330.

FIG. 5 illustrates an exploded view of the elongate tubular member 360and handle 370 free of elongate member 301. Handle 370 comprises a firstportion 372 and a second portion 380. First portion 372 is attached tothe distal end 364 of elongate tubular member 360 and comprises aproximal end 373, distal end 374, shaft 375, threaded portion 376, andone or more projections 377.

Shaft 375 extends from the proximal end 373 towards the distal end 374to threaded portion 376. The body 371 of first portion 372 definesthreaded portion 376, which extends from the distal end of shaft 375towards distal end 374 and is disposed between shaft 375 and the one ormore projections 377. Threaded portion 376 comprises a circumferentiallyoutwardly extending helical ridge.

The one or more projections 377 extend about the entirety, or a portion,of the circumference of the distal end of threaded portion 376 to thedistal end 374 of first portion 372. The one or more projections 377form a collet configuration that extends from the distal end of threadedportion 376 to the distal end 374 of first portion 372. The one or moreprojections 377 can optionally comprise one or more inwardly extendingteeth and/or ridges on a portion, or the entirety, of the interiorsurface of the one or more projections 377 to assist with attachinghandle 370 to the elongate member 301.

The body 371 of first portion 372 defines an aperture 378 that extendsthrough shaft 375 and threaded portion 376 from an opening at theproximal end 373 of first portion 372 to an opening at the distal end ofthreaded portion 376. Aperture 378 provides access through the length offirst portion 372 and has a diameter 379 that is greater than the outerdiameter 366 of elongate tubular member 360 and the outer diameter 312of the proximal portion 306 of elongate member 301. Alternatively, aproximal portion of aperture 378 can have a diameter 379 that is greaterthan the outer diameter 366 of elongate tubular member 360 a distalportion of aperture 378 such that a ridge is defined within the aperture378. This structural arrangement is considered advantageous at leastbecause it provides a mechanical stop to distal advancement of thedistal end 364 of elongate tubular member 360 within aperture 378. Thus,distal end 364 can be disposed at the ridge defined within aperture 378.

The first portion 372 of handle 370 is attached to the distal end 364 ofelongate tubular member 360 using any suitable method of attachment, andskilled artisans will be able to select a suitable method of attachmentaccording to a particular embodiment based on various considerations,such as the intended use of probe 300. Examples of suitable methods ofattachment include, but are not limited to, using an adhesive, welding,and/or using integrated components.

The second portion 380 of handle 370 comprises a proximal end 382,distal end 384, shaft 385, and a body 381 that defines a recess 386 andan aperture 387. Shaft 385 extends from the proximal end 382 to thedistal end 384 of second portion 380. Recess 386 extends from theproximal end 382 of second portion 380 into shaft 385 towards the distalend 384 to base 388. The interior wall 390 of body 381 defines athreaded portion 389, which comprises a circumferentially outwardlyextending helical ridge that extends from the proximal end 382 towardsthe distal end 384 of second portion 380. Threaded portion 389 of secondportion 380 complements threaded portion 376 of first portion 372 suchthat releasable attachment between the first portion 372 and secondportion 380 can be accomplished.

Recess 386 has a tapered configuration from the distal end of threadedportion 389 to base 388 and is adapted to receive the one or moreprojections 377 of first portion 372. Aperture 387 extends from anopening on base 388 of recess 386 to an opening on the distal end 384 ofsecond portion 380. Aperture 387 has a diameter that is greater than theouter diameter 312 of proximal portion 306 of elongate member 301.Alternatively, aperture 387 can comprise any suitable diameter. Forexample, aperture 387 can have a diameter that is greater than the outerdiameter of 308, or outer diameter of 310, depending on the placement ofthe handle 370 along elongate member 306. Thus, any aperture of a handlecan have a diameter that is equal to, substantially equal to, or greaterthan the portion of an elongate member that is disposed through theaperture.

In use, prior to, during, or subsequent to probe 300 being attached to ahandle of a lithotripter using a sleeve, or other means of attachment,the elongate tubular member 360 and handle 370 can be releasablyattached to elongate member 301. This can be accomplished by insertingthe distal end 304 of elongate member 301 through the lumen 367 ofelongate tubular member 360, aperture 378 of first portion 372, andaperture 387 of second portion 380. To releasably attach elongatetubular member 360 and handle 370 along a portion of the length ofelongate member 301, a user moves handle 370 from its firstconfiguration to its second configuration. In the first configurationthreaded portion 376 of first portion 372 is free of threaded portion389 of second portion 380 and elongate tubular member 360 and handle 370are slidably disposed along the length of elongate member 301. In thefirst configuration, the one or more projections 377 define a firstinside diameter that is greater than, or slightly greater than, theouter diameter 312 of the proximal portion 306 of elongate member 301,or greater than the outer diameter 316 of the distal portion 310 ofelongate member 301, allowing elongate tubular member 360 and firstportion 372 to be slidable along the length of elongate member 301.Alternatively, the one or more projections 377 can define a first insidediameter that is greater than, or slightly greater than, the outerdiameter of the intermediate portion 308.

In the second configuration, threaded portion 376 of first portion 372is engaged with threaded portion 389 of second portion 380 such that theone or more projections 377 are disposed within the taperedconfiguration of recess 386 of second portion 380, releasably attachingelongate tubular member 360 and handle 370 to elongate member 301. Thus,the first portion 372 is releasably attached to the second portion 380.The tapered configuration of recess 386 compresses a portion, or theentirety, of the one or more projections 377 against the exteriorsurface of elongate member 301 to engage and/or lock handle 370 in placealong the length of elongate member 301. Thus, in the secondconfiguration, the one or more projections 377 define a second insidediameter that is equal to, or substantially equal to, the outer diameterof elongate member 301.

Elongate tubular member 360 and handle 370 can advantageously be removedfrom elongate member 301 and/or adjusted along the length of elongatemember 301 as desired by a user. To accomplish adjusting the position ofelongate tubular member 360 and handle 370 a user moves handle 370 fromthe second configuration to the first configuration, or a positionbetween the second configuration and the first configuration.Subsequently, the user slides the elongate tubular member 360 and handle370 to a desired position along the length of elongate member 301 andmoves the handle 370 back to the second configuration. To accomplishremoving the elongate tubular member 360 and handle 370 from elongatemember 301 a user moves the handle 370 from the second configuration tothe first configuration, or a position between the second configurationand the first configuration, and slides the elongate tubular member 360and handle 370 off of elongate member 301.

Elongate tubular member 360 and handle 370 can be formed of any suitablematerial, and skilled artisans will be able to select an appropriatematerial according to a particular embodiment based on variousconsiderations, such as the intended use of the probe. Example materialsconsidered suitable include, but are not limited to, metals, stainlesssteel, nickel titanium, cobalt chromium, plastics, polymers,biocompatible materials, materials that can be made biocompatible, orvariations thereof. In addition, while first portion 372 has beendescribed as having threaded portion 376 and second portion 380 has beendescribed as having threaded portion 389, other methods of providingreleasable attachment between first portion 372 and second portion 380are considered suitable, and skilled artisans will be able to select anappropriate method of attachment based on various considerations, suchas the outer diameter of the probe being utilized. Example methods ofattachment considered suitable between first portion and second portioninclude, but are not limited to, providing a snap fit, pin vice, and/ora Morse taper.

Optionally, elongate member 301 can comprise one or more indicia (e.g.,markers) disposed along its length, which correlate with a length ofelongate member 301 that extends distal and/or proximal to the one ormore indicia. Any suitable form of measurement can be utilized toindicate the length of elongate member 301 that is disposed distaland/or proximal to the one or more indicia, and skilled artisans will beable to select a suitable form of measurement based on variousconsiderations, such as the bodily passage in which the probe will beused. The one or more indicia can be embedded within, and/or disposed onthe exterior surface of elongate member 301. Alternatively, each of theone or more indicia can comprise a raised protuberance extendingradially outward from the exterior surface of elongate member 301. Theraised protuberance can extend about the entirety of the circumference,or a portion of the circumference, of elongate member 301. The inclusionof a raised protuberance is considered advantageous at least because itprovides a user with tactile feedback as to the disposition of handle370 along the length of elongate member 301 as it is being releasablyattached to elongate member 301, allowing the user to releasablyattached handle 370 at a particular location along the length ofelongate member 301. To assist with positioning handle 370 at aparticular location along the length of elongate member 301, handle 370can optionally comprise one or more recesses adapted to receive one ofthe one or more raised protuberances. The one or more recesses cancircumferentially extend around the entirety, or a portion, of theinterior surface of aperture 378 of first portion 372 and/or aperture387 of second portion 380.

Elongate member 301 can also optionally comprise a roughened surfacedisposed along the entirety, or a portion, of its length. The inclusionof a roughened surface along the entirety, or a portion, of the lengthof elongate member 301 is considered advantageous at least because itdecreases the likelihood of handle 370 sliding from its position duringuse. The roughened surface can be accomplished using any suitablemethod, and skilled artisans will be able to select a suitable methodaccording to a particular embodiment based on various considerations,such as the desired roughness to be provided on the entirety, or aportion, of the length of elongate member. Example methods consideredsuitable for producing a roughened surface along the entirety, or aportion, of the length of elongate member 301 include, but are notlimited to, grit blasting, sanding, and/or etching.

In use, handle 370 advantageously provides a user with fine motorcontrol of probe 300 and tactile feedback relating to the treatment areaand/or bodily passage. Fine motor control is considered advantageous atleast because it allows a user to properly position the distal end 304of elongate member 301 prior to activating a handle of a lithotripter.For example, when a stone is being fragmented for removal from asalivary duct, handle 370 provides a user with the ability to finelycontrol the advancement of elongate member 301 and provides tactilefeedback as to when the distal end 304 of elongate member 301 is incontact with a stone.

While elongate tubular member 360 and/or handle 370 have been describedand illustrated as being used in combination with elongate member 301,elongate tubular member 360 and/or handle 370 can be used in combinationwith any suitable elongate member. A skilled artisan will be able toselect a suitable elongate member to use in combination with elongatetubular member 360 and/or handle 370 based on various considerations,such as the bodily passage in which the elongate member will be used.Example elongate members considered suitable for use in combination withelongate tubular member 360 and/or handle 370 include, but are notlimited to, elongate member 101, elongate member 101′, elongate member201, and any other suitable elongate member, such as an elongate memberwith a continuous, or substantially continuous, outer diameter along itslength.

Optionally, the proximal portion 306 of elongate member 301 can includea radially outwardly extending collar disposed along its length thatprevents elongate tubular member 360 and/or handle 370 from beingattached to elongate member 301 at a location proximal to the collar.Thus, the collar provides a mechanical stop to the proximal progressionof elongate tubular member 360 and/or handle 370 when it is beingattached to elongate member 301. The collar can comprise a separateelement that is slidably disposed along the length of elongate member301, or be integral with elongate member 301. If the collar is integralwith elongate member 301, the collar has an outer diameter that is lessthan the outer diameter 337 of the first member 336 and the outerdiameter 339 of the second member 338 of fitting 330 to allow forattachment of probe 300 to a lithotripter.

Furthermore, while a particular handle 370 has been described andillustrated as disposed along the length of elongate member 301, anysuitable structure can be used to provide a user with fine motorcontrol, and skilled artisans will be able to select a suitablestructure to use with an elongate member according to a particularembodiment based on various considerations, including the bodily passagewithin which an elongate member is intended to be used. Examplealternative structures considered suitable to include with an elongatemember include, but are not limited to, a control handle such as any ofthose described in U.S. Provisional Patent Application No. 61/533,190,filed Sep. 10, 2011, and co-pending U.S. patent application Ser. No.13/608,002, filed Sep. 10, 2012, each of which is hereby incorporated byreference in its entirety, and any other suitable structure.

Optionally, elongate tubular member 360 can be omitted and handle 370can be used independent of elongate tubular member 360, as illustratedin FIG. 5A. As shown in FIG. 5A, a probe 300′ comprises an elongatemember 301′ having a proximal portion 306′, an intermediate portion308′, and a distal portion 310′. Handle 370′ is releasably attachedalong the length of elongate member 301′ and is in the secondconfiguration. In the illustrated embodiment, probe 300′ does notinclude an elongate tubular member, such as elongate tubular member 360,such that handle 370′ can be used independently and be positioned at anysuitable location along the length of elongate member 301′.

Any of the elements, features, and/or structural arrangements describedherein with respect to any probe, handle, and/or elongate tubular membercan be combined in any suitable manner, and skilled artisans will beable to select a suitable element, feature, and/or structuralarrangement for a probe, handle, and/or elongate tubular memberaccording to a particular embodiment based on various considerations,such as the desired bodily passage within which a probe is intended tobe deployed.

FIG. 6 illustrates probe 300 and sheath 400 partially disposed in theopening 420 (e.g., papilla) of a salivary duct 422 that has a stone 424disposed in its length. The probe 300 is similar to that described abovewith respect to FIG. 3, except as described. While a salivary duct hasbeen described and illustrated as having a stone disposed in its length,any of the probes, elongate tubular members, and handles describedherein can be used in any suitable bodily passage, such as a portion ofthe urinary tract, and skilled artisans will be able to select asuitable probe, elongate tubular member, and/or handle for use in aparticular bodily passage based on various considerations, such as thelocation of the stone within the bodily passage.

The sheath 400 advantageously allows for the introduction of treatmentdevices into the salivary duct 422 and comprises a proximal end 402, adistal end 404, length 405, and defines a lumen 406 that extends betweenan openings at the proximal end 402 and distal end 404. The sheath 400can be formed out of any suitable material and can have any suitablelength, and skilled artisans will be able to select a suitable sheath400 based on various considerations, such as the bodily passage in whichthe sheath will be disposed. The inventor has determined that sheathshaving a length between about 0.5 centimeters to about 7.0 centimetersare suitable. In addition, the inventor has determined that sheathshaving a length between about 1.0 centimeter to about 5.0 centimetersare suitable. For example, the inventor has determined that sheathshaving a length about, equal to, or substantially equal to, 1.0centimeter are suitable for use in the parotid ducts or submandibularducts. Furthermore, the inventor has determined that sheaths having alength about, equal to, or substantially equal to, 5.0 centimeters aresuitable for use in the submandibular ducts or submandibular ducts.

While a sheath 400 has been illustrated in FIG. 6, other various devicescan be utilized in combination with the probes described herein. Forexample, alternative to using a sheath, a scope defining at least onelumen can be used in combination with the probes described herein. Nomatter the device used in combination with the probes described herein,the lumen 406 of the sheath 400, or the lumen (e.g., working channel) ofa scope, or other device, can have any suitable inner diameter, andskilled artisans will be able to select a suitable device according to aparticular embodiment based on various considerations, such as the outerdiameter of the probe being used. The inventor has determined thatsheaths, or scopes, defining a lumen having an inner diameter betweenabout 0.1 millimeters to about 1.1 millimeters are suitable. Inaddition, the inventor has determined that sheaths, or scopes, defininga lumen having an inner diameter between about 0.35 millimeters to about0.85 millimeters are suitable. Furthermore, the inventor has determinedthat a sheath, or scope, defining a lumen having an inner diameterabout, equal to, or substantially equal to, 0.65 millimeters issuitable. Moreover, the inventor has determined that a sheath, or scope,defining a lumen having an inner diameter about, equal to, orsubstantially equal to, 0.45 millimeters is suitable.

Probe 300 is attached to lithotripter 430 by attaching sleeve 432 overfitting 330. Attachment of the sleeve 432 to the lithotripter 430 can beaccomplished using any suitable method, and skilled artisans will beable to select a suitable method of attachment based on variousconsiderations, such as the type of lithotripter being used. Examplemethods of attachment considered suitable include, but are not limitedto, using one or more threaded components, a snap fit, or a frictionfit.

Distal portion 310 of elongate member 301 has a length 318 that isgreater than the length 405 of sheath 400 to allow for the distal end304 of elongate member 301 to extend past the distal end 404 of sheath400. Positioning the distal end 304 of elongate member 301 beyond thedistal end 404 of sheath 400 can be accomplished by a user placing adistal force, indicated by arrow 434, on a portion of lithotripter 430,handle 370, and/or a portion of probe 300. It is considered advantageousto place the distal force on handle 370 at least to provide tactilefeedback while probe is in use or being passed through a bodily passage.As described above, distal portion 310 is flexible, or substantiallyflexible, which allows it to be advanced through tortuous passages usingthe lumen 406 of sheath 400 to reinforce its position.

As the distal end 304 of elongate member 301 is passed through the lumen406 of sheath 400, the distal end 384 of the second portion 380 ofhandle 370 acts as a mechanical stop by interacting with the proximalend 402 of sheath 400. This advantageously prevents inadvertentadvancement of elongate member 301 through the lumen 406 of sheath 400beyond the position of handle 370. Thus, only the length of elongatemember 301 positioned distal to handle 370 can be disposed through thelumen 406 of the sheath 400 and into the salivary duct 422.

In use, the distal end 304 of elongate member 301 is advanced towardsstone 424 until the distal end 304 contacts stone 424. Subsequently, thefiring handle 434 of lithotripter 430 is activated to transmit energyprovided by an energy source (e.g., CO₂ cartridge) through elongatemember 301 and to stone 424 so that it can be fragmented and removedfrom the salivary duct 422 using any suitable medical device, such as anirrigation device, suction device, graspers, forceps, and/or baskets.

FIG. 7 illustrates probe 300, sheath 400, and scope 440 partiallydisposed in the opening 420 (e.g., papilla) of a salivary duct 422 thathas a stone 424 disposed in its length. In the illustrated embodiment,probe 300 is disposed through a first lumen 446 defined by scope 440.Sheath 400 and probe 300 are similar to that described above withrespect to FIG. 6, except as described below. Reference numbers in FIG.7 refer to the same structural element or feature referenced by the samenumber in FIG. 6. While a salivary duct has been described andillustrated as having a stone disposed in its length, any of the probes,elongate tubular members, and handles described herein can be used inany suitable bodily passage, such as a portion of the urinary tract, andskilled artisans will be able to select a suitable probe, elongatetubular member, and/or handle for use in a particular bodily passagebased on various considerations, such as the location of the stonewithin the bodily passage. While sheath 400 has been illustrated, it isconsidered optional and can be omitted (e.g., omitted from the methodsdescribed herein).

Scope 440 comprises a proximal end 442, a distal end 444, and defines afirst lumen 446, second lumen 448, and passageway 450. The first lumen446 extends between an opening 452 at the proximal end 442 and anopening 454 at the distal end 444 and has a length 447. The first lumen446 (e.g., the working channel of the scope) is adapted to receive alength of probe 300. The second lumen 448 extends between an opening 456at the proximal end 442 and an opening 458 at the distal end 444.Passageway 450 extends between an opening 460 at the proximal end 442and an opening 462 at the distal end 444. The second lumen 448 andpassageway 450 are adapted to receive any suitable material, structure,and/or device, and skilled artisans will be able to select a suitablematerial, structure, and/or device to pass through a lumen and/orpassageway of a scope according to a particular embodiment based onvarious considerations, such as the bodily passage within which thedistal end of a scope is intended to be used. Example materials,structures, and devices considered suitable to pass through second lumen448 and/or passageway 450 include, but are not limited to, an irrigationdevice, suction device, graspers, forceps, basket, light source, opticsource, optical fiber, camera, chip-in-tip fiber optics, a probe, suchas any of those described herein, and materials used to flush and/orirrigate a bodily passage. For example, second lumen 448 can be adaptedto provide irrigation to salivary duct 422 such that the salivary duct422 distends relative to its normal structural arrangement andpassageway 450 can be adapted to pass optics (e.g., camera, chip-in-tipfibers) and/or light sources (e.g., optical fiber) through lumen 450.

Scope 440 can be formed out of any suitable material, can have anysuitable length, and any suitable number of lumens, and skilled artisanswill be able to select a suitable scope based on various considerations,such as the bodily passage within which a probe is intended to be used.In addition, while a particular structure has been illustrated anddescribed with respect to scope 440, a scope having any suitablestructure capable of providing a lumen adapted to receive a length of aprobe is considered suitable. Skilled artisans will be able to select asuitable structure for a probe according to a particular embodimentbased on various considerations, such as the bodily passage within whicha probe is intended to be used. For example, the distal end of a scopecan be formed of a rigid, substantially rigid, flexible, orsubstantially flexibly material, and/or form one or more curves alongits length such that it can be navigated through tortuous bodilypassages.

Scope 440 extends through the lumen 406 of sheath 400 such that thedistal end 444 of scope is positioned distal to the distal end 404 ofsheath 400. Distal portion 310 of elongate member 301 has a length 318that is greater than the length 447 of the first lumen 446 to allow thedistal end 304 of elongate member 301 to extend past the distal end 444of scope 440. As the distal end 304 of elongate member 301 is passedthrough the first lumen 446 of scope 440, the distal end 384 of thesecond portion 380 of handle 370 acts as a mechanical stop byinteracting with the proximal end 442 of scope 440. This advantageouslyprevents inadvertent advancement of elongate member 301 through thefirst lumen 446 beyond the position of distal end 384. Thus, only thelength of elongate member 301 positioned distal to distal end 384 can bedisposed through the first lumen 446 of the scope 440 and into thesalivary duct 422. In use, it is considered advantageous to maintain aclearance between the distal end 384 of the second portion 380 of handle370 and the proximal end 442 of scope 440 to prevent reducing the powerbeing transmitted along the length of probe 300.

In use, the distal end 304 of elongate member 301 is advanced towardsstone 424 until the distal end 304 contacts stone 424. Subsequently, thefiring handle of lithotripter is activated to transmit energy providedby an energy source (e.g., CO₂ cartridge) through elongate member 301and to stone 424 so that it can be fragmented and removed from thesalivary duct 422 using any suitable medical device, such as anirrigation device, suction device, graspers, forceps, and/or baskets.

FIGS. 7A and 7B are similar to FIG. 7, except as described below. In theillustrated embodiment, alternative to elongate member 301 beingutilized, elongate member 101′ is utilized and disposed through a firstlumen 446 defined by scope 440. Elongate member 101′ is similar to thatdescribed above with respect to FIG. 1A and sheath 400 and scope 440 aresimilar to that described above with respect to FIG. 7, except asdescribed below. Reference numbers in FIGS. 7A and 7B refer to the samestructural element or feature referenced by the same number in FIG. 1Aand FIG. 7. Thus, elongate member 101′ comprises a proximal end (notshown), distal end 104′ and defines a curve 155′.

In the illustrated embodiment, salivary duct 422 has a stone 424disposed in its length beyond a curve 423 defined by the salivary ductwall 425. While a salivary duct has been described and illustrated ashaving a stone disposed in its length, any of the probes, elongatetubular members, and handles described herein can be used in anysuitable bodily passage, such as a portion of the urinary tract, andskilled artisans will be able to select a suitable probe, elongatetubular member, and/or handle for use in a particular bodily passagebased on various considerations, such as the location of the stonewithin the bodily passage.

In the illustrated embodiment, sheath 400 is partially disposed in theopening 420 (e.g., papilla) of salivary duct 422 such that sheath distalend 404 is disposed within the salivary duct 422. Scope 440 extendsthrough the lumen 406 of sheath 400 such that the distal end 444 ofscope is positioned distal to the distal end 404 of sheath 400. Distalportion 110′ of elongate member 101′ has a length that is greater thanthe length of the first lumen 446 of scope 440 to allow the distal end104′ of elongate member 101′ to extend past the distal end 444 of scope440.

As illustrated in FIG. 7A, elongate member 101′ is in the straight, orsubstantially straight, configuration when it is disposed within thefirst lumen 446 of scope 440. As elongate member 101′ is advanceddistally, as indicated by arrow 434, and a portion, or the entirety, ofelongate member curve 155′ is advanced distal to the distal end 444 ofscope 440, elongate member 101′ begins to move from the straight, orsubstantially straight, configuration to the curved configuration, asillustrated in FIG. 7B. Movement of the elongate member 101′ between thestraight, or substantially straight, configuration to the curvedconfiguration is considered advantageous at least because it provides amechanism for advancing elongate member 101′ distal to, or beyond, thecurve 423 defined in salivary duct 422. In addition, movement ofelongate member 101′ between the straight, or substantially straight,configuration and the curved configuration is considered advantageous atleast because it provides a mechanism for advancing elongate member 101′to a stone disposed within, or beyond, a curve 423, or that is offsetfrom the scope 440.

In use, the distal end 104′ of elongate member 101′ is advanced towardsstone 424 until the distal end 104′ contacts stone 424. Subsequently,the firing handle of lithotripter is activated to transmit energyprovided by an energy source (e.g., CO₂ cartridge) through elongatemember 101′ and to stone 424 so that it can be fragmented and removedfrom the salivary duct 422 using any suitable medical device, such as anirrigation device, suction device, graspers, forceps, and/or baskets.

Various methods, steps, optional steps, and alternative steps ofperforming lithotripsy are provided. These methods, steps, optionalsteps, and alternative steps include performing lithotripsy in a bodilypassage, such as a salivary duct or a portion of the urinary tract.While the methods, steps, optional steps, and alternative steps ofperforming lithotripsy are exemplified by methods, steps, optionalsteps, and alternative steps of performing pneumatic lithotripsy withina salivary duct to remove a stone disposed therein, the methods, steps,optional steps, and alternative steps can include any suitable form oflithotripsy (e.g., laser lithotripsy) and can be used to treat anyailment or suitable bodily passage (e.g., urinary tract). Furthermore,while the methods, steps, optional steps, and alternative stepsdescribed herein are shown and described as a series of acts, it is tobe understood and appreciated that the methods, steps, optional steps,and alternative steps are not limited by the order of acts, as some actsmay, in accordance with these methods, occur in different orders, beomitted, and/or occur concurrently with other acts described herein.

FIG. 8 is a flowchart representation of an exemplary method 500 ofperforming pneumatic lithotripsy using a probe to remove a stonedisposed in a salivary duct having a salivary duct opening. An initialstep 502 comprises inserting a sheath having a proximal end and a distalend through a salivary duct opening such that the distal end of thesheath is disposed past the salivary duct opening and in the salivaryduct. The sheath defines a lumen that extends between an opening at theproximal end and an opening at the distal end of the sheath andcomprises a first inner diameter and a sheath lumen length that extendsfrom the opening at the proximal end and the opening at the distal end.Another step 504 comprises inserting a scope having a proximal end and adistal end through the lumen of the sheath such that the distal end ofthe scope is disposed distal to the distal end of the sheath. The scopedefines at least one lumen that extends between an opening at, or near,the proximal end and an opening at the distal end of the scope, andcomprises a second inner diameter and a scope lumen length that extendsfrom the opening at, or near, the proximal end to the opening at thedistal end. Another step 506 comprises inserting a lithotriptercomprising a firing handle and a probe having a proximal end and adistal end through the lumen of the scope such that the distal end ofthe probe is disposed distal to the distal end of the scope. The probeis attached to the lithotripter and comprises an elongate member,fitting, O-ring, elongate tubular member, and a handle, and is similarto probe 300. The elongate member comprises a proximal portion, anintermediate portion, and a distal portion. The proximal portion of theelongate member has a first length and a first outer diameter. Theintermediate portion of the elongate member has a second length and asecond outer diameter. The distal portion of the elongate member has athird length and a third outer diameter. The first outer diameter of theproximal portion is greater than the third outer diameter of the distalportion and the third outer diameter of the distal portion is less thanthe second inner diameter of the lumen of the scope. The third length ofthe distal portion is greater than the scope lumen length. Another step508 comprises navigating the distal end of the probe towards the stonedisposed within the salivary duct. Another step 510 comprises contactingthe distal end of the probe with the stone. Another step 512 comprisesactivating the firing handle to transmit energy through the probe and tothe stone to fragment the stone. Another step 514 comprises removing theprobe from the lumen of the scope. Another step 516 comprises removingthe scope from the lumen of the sheath. Another step 518 comprisesinserting an irrigation device having a proximal end and a distal endthrough the lumen of the sheath such that the distal end of theirrigation device is disposed distal to the distal end of the sheath.Another step 520 comprises activating the irrigation device to flush outthe stone fragments. Another step 522 comprises removing the irrigationdevice from the lumen of the sheath. Another step 524 comprisesinserting a scope having a proximal end and a distal end through thelumen of the sheath such that the distal end of the scope is disposeddistal to the distal end of the sheath. Another step 526 comprisesconfirming removal of the stone fragments from the salivary duct.Another step 528 comprises removing the scope from the lumen of thesheath. Another step 530 comprises removing the sheath from the salivaryduct and salivary duct opening.

The step 502 of inserting a sheath having a proximal end and a distalend through a salivary duct opening such that the distal end of thesheath is disposed past the salivary duct opening and in the salivaryduct can be accomplished by locating an opening of a salivary duct andinserting the distal end of the sheath into and through the opening ofthe salivary duct. The opening of the salivary duct can comprise anysuitable opening for completing a procedure.

Step 502 can be accomplished using any suitable sheath formed of anysuitable material, having any suitable length, and defining at least onelumen, and skilled artisans will be able to select a suitable sheathbased on various considerations, including the bodily passage withinwhich a sheath is intended to be deployed. The inventor has determinedthat sheaths having a length between about 0.5 centimeters to about 7.0centimeters are suitable. In addition, the inventor has determined thatsheaths having a length between about 1.0 centimeter to about 5.0centimeters are suitable. For example, the inventor has determined thatsheaths having a length about, equal to, or substantially equal to, 1.0centimeter are suitable for use in the parotid ducts or submandibularducts. In a further example, the inventor has determined that sheathshaving a length about, equal to, or substantially equal to, 5.0centimeters are suitable for use in the submandibular ducts orsubmandibular ducts.

While step 502 has been described as using a sheath to provide access toa salivary duct, other devices and bodily passages are consideredsuitable, and skilled artisans will be able to select a suitable deviceand/or bodily passage according to a particular embodiment based onvarious considerations, such as the desired treatment intended to beperformed. An example of a suitable device includes, but is not limitedto, a scope defining at least one lumen. Alternatively, this step can beomitted such that a scope is inserted through a salivary duct openingsuch that the distal end of the scope is disposed past the salivary ductopening and in the salivary duct. Thus, method 500 can be accomplishedwithout a sheath and using a scope.

The step 504 of inserting a scope having a proximal end and a distal endthrough the lumen of the sheath such that the distal end of the scope isdisposed distal to the distal end of the sheath can be accomplished bylocating the opening defined on the proximal end of the sheath andinserting the distal end of the scope into and through the opening ofthe sheath. Step 504 can be accomplished using any suitable scope formedof any suitable material, having any suitable length, and defining atleast one lumen, and skilled artisans will be able to select a suitablescope based on various considerations, including the bodily passagewithin which a scope is intended to be deployed.

The step 506 of inserting a lithotripter comprising a firing handle anda probe having a proximal end and a distal end through the lumen of thescope such that the distal end of the probe is disposed distal to thedistal end of the scope can be accomplished by locating the openingdefined on, or near, the proximal end of the scope and inserting thedistal end of the probe into and through the opening of the scope, asillustrated in FIG. 7.

While step 506 has been described as accomplished with a probe thatcomprises an elongate member, fitting, O-ring, elongate tubular member,and a handle, which is similar to probe 300, any suitable probe can beused to accomplished step 506 and method 500. Skilled artisans will beable to select a suitable probe according to a particular embodimentbased on various considerations, such as the bodily passage within whicha probe is intended to be used. Example probes considered suitableinclude, but are not limited to, probe 100, probe 101′, probe 200, probe300, any variation of the probes described herein, and any othersuitable probe.

In addition, while step 506 has been described as being accomplishedusing a lithotripter having a firing handle, step 506 can beaccomplished using any suitable lithotripter, and skilled artisans willbe able to select a suitable lithotripter according to a particularembodiment based on various considerations, such as the structuralconfiguration of a probe intended to be used with the lithotripter.Example lithotripters considered suitable to perform one or more steps,or methods, described herein include, but are not limited to, laserlithotripters, and any other lithotripter considered suitable for aparticular application.

Alternative to inserting a probe through the lumen of a scope, step 504can be omitted, and step 506 can be accomplished by inserting a probethrough the lumen of a sheath.

The step 508 of navigating the distal end of the probe towards the stonedisposed within the salivary duct can be accomplished by placing adistal force on any portion of the probe, handle, and/or lithotripter toprovide axial movement of the distal end of the probe through thesalivary duct. Step 508 can be accomplished using direct visualization,using a wire guide, and/or with the aid of a scope.

The step 510 of contacting the distal end of the probe with the stonecan be accomplished using direct visualization, with the aid of a scope,and/or through tactile feedback through the probe and/or handle.

The step 512 of activating the firing handle to transmit energy throughthe probe and to the stone to fragment the stone can be accomplished bydepressing the firing handle of the lithotripter. It is to beunderstood, however, that while a pneumatic lithotripter has been usedas an example for performing the method 500, the methods and probeconfigurations described herein are not limited to pneumaticlithotripsy, and can be utilized in combination with other suitableforms of lithotripsy and to complete a procedure in any suitable bodilypassage.

The step 514 of removing the probe from the lumen of the scope can beaccomplished by applying a proximal force on any suitable portion of theprobe, handle, and/or a portion of the lithotripter until the probe iscompletely removed from the salivary duct and scope.

The step 516 of removing the scope from the lumen of the sheath can beaccomplished by applying a proximal force on any suitable portion of thescope until the scope is completely removed from the salivary duct andsheath. Alternatively, when a scope is passed into a salivary ductindependent of a sheath, this step can comprise removing the scope fromthe salivary duct and the salivary duct opening. Alternatively, thisstep can be omitted.

The step 518 of inserting an irrigation device having a proximal end anda distal end through the lumen of the sheath such that the distal end ofthe irrigation device is disposed distal to the distal end of the sheathcan be accomplished by locating the opening defined on the proximal endof the sheath and inserting the distal end of the irrigation device intoand through the opening of the sheath. Step 518 can be accomplishedusing any suitable irrigation device that is adapted to introduce anysuitable fluid (e.g., water, saline) into a bodily passage to assistwith the removal of material (e.g., stone fragments) from the bodilypassage. Alternatively, this step can be accomplished by inserting anirrigation device having a proximal end and a distal end through a lumenof the scope such that the distal end of the irrigation device isdisposed distal to the distal end of the scope. Alternative to advancingan irrigation device, one or more other medical devices may be advancedthrough the lumen of the sheath or a lumen of the scope and used toremove the stone, and/or stone fragments, disposed within the salivaryduct, and skilled artisans will be able to select a suitable medicaldevice based on various considerations, such as the location of thestone within the salivary duct. Example medical devices consideredsuitable include, but are not limited to, graspers, forceps, and/orbaskets.

The step 520 of activating the irrigation device to flush out the stonefragments can be accomplished by a user activating a power source tointroduce any suitable fluid (e.g., water, saline) into the salivaryduct to assist with the removal of material (e.g., stone fragments) fromthe salivary duct.

The step 522 of removing the irrigation device from the lumen of thesheath can be accomplished by applying a proximal force on any suitableportion of the irrigation device until the irrigation device iscompletely removed from the salivary duct and sheath. Alternatively,this step can comprise removing the irrigation device from the lumen ofthe scope.

The step 524 of inserting a scope having a proximal end and a distal endthrough the lumen of the sheath such that the distal end of the scope isdisposed distal to the distal end of the sheath can be accomplished bylocating the opening defined on the proximal end of the sheath andinserting the distal end of the scope into and through the opening ofthe sheath. Step 524 can be accomplished using any suitable scope formedof any suitable material, having any suitable length, and defining atleast one lumen, and skilled artisans will be able to select a suitablescope based on various considerations, including the bodily passagewithin which a scope is intended to be deployed. Alternatively, thisstep can be omitted.

The step 526 of confirming removal of the stone fragments from thesalivary duct can be accomplished using the scope, direct visualization,or any other suitable method and/or device, and skilled artisans will beable to select a suitable method and/or device to confirm removal ofstone fragments from a salivary duct according to a particularembodiment based on various considerations, such as the bodily passagewithin which the stone fragments are disposed.

Optionally, one or more of step 506, step 508, step 510, step 512, stepand 514 can be repeated if it is determined that additional stones aredisposed within the salivary duct.

The step 528 of removing the scope from the lumen of the sheath can beaccomplished by applying a proximal force on any suitable portion of thescope until the scope is completely removed from the salivary duct andthe lumen of the sheath.

The step 530 of removing the sheath from the salivary duct and salivaryduct opening can be accomplished by applying a proximal force on anysuitable portion of the sheath until the sheath is completely removedfrom the salivary duct and the salivary duct opening. Optionally, thestep of removing the scope from the lumen of the sheath can beaccomplished in combination with the step of removing the sheath fromthe salivary duct and salivary duct opening. Optionally, this step canbe omitted.

It is considered advantageous to complete method 500 in the orderillustrated and/or described. In is noted however, that any order isconsidered suitable.

FIG. 9 is a flowchart representation of another exemplary method 600 ofperforming pneumatic lithotripsy using a probe to remove a stonedisposed in a salivary duct. The salivary duct has a salivary duct walldefining a salivary duct opening and a curve. The stone is disposeddistal to, or beyond, the curve defined by the salivary duct wall.

An initial step 602 comprises inserting a sheath having a proximal endand a distal end through the salivary duct opening such that the distalend of the sheath is disposed past the salivary duct opening and in thesalivary duct. The sheath defines a lumen that extends between anopening at the proximal end of the sheath and an opening at the distalend of the sheath and comprises a first inner diameter and a sheathlumen length that extends from the opening at the proximal end and theopening at the distal end. Another step 604 comprises inserting a scopehaving a proximal end and a distal end through the lumen of the sheathsuch that the distal end of the scope is disposed distal to the distalend of the sheath. The scope defines at least one lumen that extendsbetween an opening at, or near, the proximal end and an opening at thedistal end of the scope, and comprises a second inner diameter and ascope lumen length that extends from the opening at, or near, theproximal end to the opening at the distal end. Another step 606comprises inserting a lithotripter comprising a firing handle and aprobe having a proximal end and a distal end through the lumen of thescope such that the distal end of the probe is disposed distal to thedistal end of the scope. An exemplary probe considered suitable toperform method 600 is probe 101′, described above. Another step 608comprises advancing the probe through the lumen of the scope such that aportion, or the entirety, of the curve defined by the elongate member isdisposed distal to the distal end of the scope. Another step 610comprises navigating the distal end of the probe towards the stonedisposed within the salivary duct. Another step 612 comprises contactingthe distal end of the probe with the stone. Another step 614 comprisesactivating the firing handle to transmit energy through the probe and tothe stone to fragment the stone. Another step 616 comprises removing theprobe from the lumen of the scope. Another step 618 comprises removingthe scope from the lumen of the sheath. Another step 620 comprisesinserting an irrigation device having a proximal end and a distal endthrough the lumen of the sheath such that the distal end of theirrigation device is disposed distal to the distal end of the sheath.Another step 622 comprises activating the irrigation device to flush outthe stone fragments. Another step 624 comprises removing the irrigationdevice from the lumen of the sheath. Another step 626 comprisesinserting a scope having a proximal end and a distal end through thelumen of the sheath such that the distal end of the scope is disposeddistal to the distal end of the sheath. Another step 628 comprisesconfirming removal of the stone fragments from the salivary duct.Another step 630 comprises removing the scope from the lumen of thesheath. Another step 632 comprises removing the sheath from the salivaryduct and salivary duct opening.

While method 600 has been described as being accomplished using asheath, it can alternatively be accomplished without a sheath and onlywith a scope. Thus, the steps requiring a particular component to bepassed through a sheath can alternatively be passed through a lumen of ascope.

Step 602 is accomplished as described above with respect to step 502.

Step 604 is accomplished as described above with respect to step 504.

The step 606 of inserting a lithotripter comprising a firing handle anda probe having a proximal end and a distal end through the lumen of thescope such that the distal end of the probe is disposed distal to thedistal end of the scope can be accomplished by locating the openingdefined on, or near, the proximal end of the scope and inserting thedistal end of the probe into and through the opening of the scope, asillustrated in FIG. 7A.

Alternative to inserting a probe through the lumen of a scope, step 606can be omitted, and step 606 can be accomplished by inserting a probethrough the lumen of a sheath.

Step 608 can be accomplished by placing a distal force on any suitableportion of the lithotripter and/or probe such that a portion, or theentirety, of the curve defined by elongate member 101′ is advanceddistal to the distal end of the scope, as illustrated in FIG. 7B.Advancing a portion, or the entirety, of curve 155′ distal to, orbeyond, the distal end of scope 440 is considered advantageous at leastbecause it provides a mechanism for navigating elongate member 101′through the tortuous anatomy of a bodily passage, such as a salivaryduct.

An optional step comprises rotating the lithotripter and/or probe suchthat the distal end of elongate member 101′ is directed toward the stonedisposed within the salivary duct. This step can be accomplished byapplying a rotational force to the lithotripter and/or probe until thedistal end of elongate member is directed toward the stone.

The remaining steps of method 600 can be accomplished as described abovein method 500.

It is considered advantageous to complete method 600 in the orderillustrated and/or described. In is noted however, that any order isconsidered suitable.

The foregoing detailed description provides exemplary embodiments of theinvention and includes the best mode for practicing the invention. Thedescription and illustration of embodiments is intended only to provideexamples of the invention, and not to limit the scope of the invention,or its protection, in any manner.

1. A method of performing lithotripsy on a stone disposed in a bodilypassage, the method comprising the steps of: inserting a sheath having afirst proximal end and a first distal end into said bodily passage suchthat the first distal end is disposed in said bodily passage, the sheathdefining a first lumen extending between an opening at the firstproximal end and an opening at the first distal end and having a firstinner diameter and first lumen length; inserting a scope having a secondproximal end and a second distal end through the first lumen such thatthe second distal end is disposed distal to the first distal end of thesheath, the scope defining a second lumen extending between an openingat the second proximal end and an opening at the second distal end andhaving a second inner diameter and second lumen length; inserting alithotripter comprising a firing handle and a probe having a thirdproximal end and a third distal end through the second lumen such thatthe third distal end is disposed distal to the second distal end of thescope, the probe comprising: an elongate member comprising a fourthproximal end, a fourth distal end, a proximal portion, an intermediateportion, and a distal portion, the proximal portion having a firstlength and a first outer diameter, the intermediate portion having asecond length and a second outer diameter, the distal portion having athird length and a third outer diameter, the intermediate portiondisposed between the proximal portion and the distal portion, the firstouter diameter being greater than the third outer diameter, the secondouter diameter tapering from the first outer diameter to the third outerdiameter, and the third length of the distal portion being greater thanthe second lumen length of the scope; and a fitting disposed on thefourth proximal end of the elongate member and adapted to attach theprobe to the lithotripter, the fitting having a fifth proximal end and afifth distal end; navigating the third distal end of the probe towardssaid stone; contacting the third distal end of the probe with saidstone; and activating the firing handle of the lithotripter to fragmentsaid stone.
 2. The method of claim 1, further comprising the steps of:removing the probe from the second lumen of the scope; removing thescope from the first lumen of the sheath; inserting a medical devicehaving a sixth proximal end and a sixth distal end through the firstlumen of the sheath such that the sixth distal end of the medical deviceis disposed distal to the first distal end of the sheath; activating themedical device to remove the fragmented stone; and removing the medicaldevice from the first lumen of the sheath.
 3. The method of claim 1,wherein the probe further comprises: an elongate tubular member disposedover a portion of the first length of the proximal portion, the elongatetubular member comprising a sixth proximal end disposed adjacent to thefifth distal end of the fitting and a sixth distal end disposed proximalto the intermediate portion; and a handle disposed over the intermediateportion of the elongate member, the handle comprising a seventh proximalend and a seventh distal end, the seventh proximal end attached to thesixth distal end of the elongate tubular member.
 4. A method ofperforming lithotripsy on a stone disposed in a bodily passage, themethod comprising: inserting a device having a first proximal end and afirst distal end into said bodily passage such that the first distal endis disposed in said bodily passage, the device defining a first lumen;inserting a lithotripter comprising a probe having a second proximal endand a second distal end through the first lumen such that the seconddistal end is disposed distal to the first distal end of the device, theprobe comprising: an elongate member comprising a third proximal end, athird distal end, a proximal portion, an intermediate portion, and adistal portion, the proximal portion having a first outer diameter, theintermediate portion having a second outer diameter, the distal portionhaving a third outer diameter, the intermediate portion disposed betweenthe proximal portion and the distal portion, the first outer diameterbeing greater than the third outer diameter, the second outer diametertapering from the first outer diameter to the third outer diameter;navigating the second distal end towards said stone; contacting thesecond distal end with said stone; and activating the lithotripter tofragment said stone.
 5. The method of claim 4, wherein the devicecomprises a sheath.
 6. The method of claim 5, wherein the sheath has alength; and wherein the distal portion has a length that is greater thanthen length of the sheath.
 7. The method of claim 6, further comprisinginserting a scope having a fourth proximal end and a fourth distal endthrough the first lumen such that the fourth distal end is disposeddistal to the first distal end of the sheath, the scope defining asecond lumen; and wherein inserting a lithotripter comprising a probehaving a second proximal end and a second distal end through the firstlumen such that the second distal end is disposed distal to the firstdistal end of the device comprises inserting a lithotripter comprising aprobe having a second proximal end and a second distal end through thesecond lumen such that the second distal end is disposed distal to thefourth distal end of the scope.
 8. The method of claim 7, furthercomprising the steps of: removing the probe from the second lumen of thescope; removing the scope from the first lumen of the sheath; insertinga medical device having a fifth proximal end and a fifth distal endthrough the first lumen of the sheath such that the fifth distal end ofthe medical device is disposed distal to the first distal end of thesheath; activating the medical device to remove fragmented stone fromsaid bodily passage; and removing the medical device from the firstlumen of the sheath.
 9. The method of claim 7, wherein the scope has alength that is greater than the length of the sheath.
 10. The method ofclaim 4, wherein the device comprises a scope.
 11. The method of claim10, further comprising the steps of: removing the probe from the firstlumen of the scope; inserting a medical device having a fourth proximalend and a fourth distal end through the first lumen of the scope suchthat the fourth distal end of the medical device is disposed distal tothe first distal end of the scope; activating the medical device toremove fragmented stone from said bodily passage; and removing themedical device from the first lumen of the scope.
 12. The method ofclaim 10, wherein the first lumen of the scope has a length; and whereinthe distal portion has a length that is greater than the length of thefirst lumen of the scope.
 13. The method of claim 4, wherein the probefurther comprises: a fitting disposed on the third proximal end of theelongate member, the fitting having a fourth proximal end and a fourthdistal end; an elongate tubular member disposed over a portion of theproximal portion, the elongate tubular member comprising a fifthproximal end and a fifth distal end, the fifth proximal end disposedadjacent to the fourth distal end of the fitting; and a handle disposedon the elongate member, the handle comprising a sixth proximal endattached to the fifth distal end of the elongate tubular member.
 14. Themethod of claim 13, wherein the fifth distal end of the elongate tubularmember is disposed proximal to the intermediate portion.
 15. The methodof claim 13, wherein the handle is moveable between a firstconfiguration and a second configuration, in the first configuration theelongate tubular member and the handle are slidably disposed on theelongate member, in the second configuration the elongate tubular memberand the handle are releasably attached to the elongate member.
 16. Themethod of claim 15, wherein the handle is disposed over the intermediateportion of the elongate member when the handle is in the secondconfiguration.
 17. The method of claim 13, wherein the entire elongatetubular member is disposed between the fourth distal end of the fittingand the second distal end of the elongate member.
 18. The method ofclaim 4, wherein said bodily passage is a salivary duct.
 19. The methodof claim 4, wherein said bodily passage is a portion of a urinary tract.20. A method of performing lithotripsy on a stone disposed in a bodilypassage, the method comprising: inserting a sheath having a firstproximal end and a first distal end into said bodily passage such thatthe first distal end is disposed in said bodily passage, the sheathhaving a length and defining a first lumen; inserting a scope having asecond proximal end and a second distal end through the first lumen ofthe sheath such that the second distal end is disposed distal to thefirst distal end of the sheath, the scope defining a second lumen havinga second lumen length; inserting a lithotripter comprising a probehaving a third proximal end and a third distal end through the secondlumen such that the third distal end is disposed distal to the seconddistal end of the scope, the probe comprising: an elongate membercomprising a fourth proximal end, a fourth distal end, a proximalportion, an intermediate portion, and a distal portion, the proximalportion having a first outer diameter, the intermediate portion having asecond outer diameter, the distal portion having a third outer diameterand a distal portion length, the intermediate portion disposed betweenthe proximal portion and the distal portion, the first outer diameterbeing greater than the third outer diameter, the second outer diametertapering from the first outer diameter to the third outer diameter, thedistal portion length being greater than the length of the sheath, thedistal portion length being greater than the second lumen length of thescope; a fitting disposed on the fourth proximal end of the elongatemember, the fitting having a fifth proximal end and a fifth distal end;an elongate tubular member disposed over a portion of the proximalportion, the elongate tubular member comprising a sixth proximal end anda sixth distal end, the sixth proximal end disposed adjacent to thefifth distal end of the fitting; and a handle disposed on the elongatemember, the handle comprising a seventh proximal end attached to thesixth distal end of the elongate tubular member; navigating the thirddistal end of the probe towards said stone; contacting the third distalend of the probe with said stone; and activating the lithotripter tofragment said stone.